Use of tissue sealants and other biological materials is an important emerging surgical technique, well adapted for the operating room or field environments such as the doctor""s office or mobile medical units. Preferred sealants include fibrin sealants which are formed from blood plasma components and comprise, on the one hand, a first component containing fibrinogen and Factor XIII and, on the other hand, a second component which usually includes thrombin and calcium ions. Until May of 1998, when the FDA first approved such products, fibrin sealants were not commercially available in the US, therefore use of fibrin sealant was limited to supplies produced within the clinic, which are not subject to FDA control. Following FDA approval, the use of fibrin sealants has been increasing steadily. During use, the fibrinogen is capable of polymerizing and being cross-linked to form a solid fibrin clot when the components are mixed. The necessary additional factors to stimulate relevant portions of the natural blood coagulation cascade are suitably distributed between the fibrinogen and thrombin components.
Antanavich et al., U.S. Pat. No. 5,585,007, whose disclosure and references are hereby incorporated herein by reference in their entirety, provides an extensive discussion of the literature relating to fibrinogen sealant preparation (column 1, line 20 to column 4, line 62) and applicators (column 4 line 62 to column 5, line 14), as well as a bibliography, (columns 6-10) and is a helpful guide to the teachings of prior workers in the field.
Depending upon the potency of the particular formulations employed, coagulation of the sealant may take place very rapidly, yielding a gel within perhaps 10 or 20 seconds. Though often very desirable for surgical reasons, such fast-acting properties present potential problems of fouling or clogging during the application process. These problems must be overcome in devising suitable applicators, methods of application, and devices suitable for filling the applicators.
A popular manually operable applicator for such two-component sealants employs a dual syringe construction wherein two syringes, connected by a yoke, each provide a reservoir for each of the components. In most prior devices, the sealant components are discharged-in separate streams and mixed externally of the applicator. Such applicators are similar in principle to household epoxy glue applicators commonly available in hardware stores.
Several devices and methods of filling biological glue applicators have been developed. For example, as taught in Epstein U.S. Pat. No. 5,266,877 and in our assignee""s international application PCT/US98/07846, components of the sealant can be placed in separate compartments of a flat filler tray for transfer to an applicator. While these device have proven useful, several shortcoming have been identified. For example, although useful as a device to permit the reliable filling of a dual syringe applicator at the point of use, such filler trays are not suitable for external storage of the sealant components. In addition, the current filling process can be time consuming and it requires a significant degree of care to efficiently transfer the sealant to the applicator. Also, a small amount of sealant will be left in the tray, and is thus wasted. Furthermore the transfer of sealant components to the multiple storage containers of the applicator raises the possibility the sterility of the sealant will be compromised during component transfer.
Thus, there is a need for a device which can effectively deliver, in a sterile environment, multiple sealant components directly from their storage containers to a syringe applicator.
The present invention solves the problem of effectively delivering multiple sealant components directly from commercially available or standardized storage containers to an applicator while allowing the use of the entire fill device within a sterile field.
In one aspect, the invention provides a filling device capable of filling a material applicator and comprises a hood defining at least one receiving aperture, an applicator interface in communication with the hood and having at least one filling port formed thereon, at least one transfer conduit in communication with the at least one filling port, at least one withdrawal cannula located within the receiving aperture and in communication with the at least one transfer conduit, and a container support device capable of receiving and supporting at least one material container in an upright tilted position within the receiving aperture. The hood may include at least one engaging surface and at least one displacement recess.
In another embodiment, the present invention is directed to a filling device for simultaneously filling at least two material reservoirs of a material applicator. The filling device comprises a hood defining a receiving aperture and having an engaging surface and at least one displacement recess formed therein. An applicator interface is in communication with the hood and includes at least two filling ports formed thereon. At least two transfer conduits are in communication with the at least two filling ports and with at least two withdrawal cannulas located within the receiving aperture. A container support device capable of receiving and supporting at least two material containers in an upright position within the hood is included. The container support device includes at least one biasing member capable of engaging the engaging surface of the hood, wherein the biasing member is capable of biasing the at least two material containers to an upright tilted position within the hood.
In yet another aspect of the present invention, another filling device capable of filling at least two material reservoirs of a syringe applicator is disclosed. The filling device of the present embodiment comprises a hood defining at least one receiving aperture having an engaging surface and a displacement recess formed therein. An applicator interface is in located on the hood and includes at least two filling ports capable of sealably engaging the syringe applicator. At least two transfer conduits in communication with the at least two filling ports and the at least two withdrawal cannulas are located within the receiving aperture. A container support device capable of receiving and supporting at least two material containers in an upright position within the hood is provided. The container support device is capable of sealably engaging the hood. In addition, a biasing member is positioned on the container support device. The biasing member is capable of engaging the engaging surface formed on the hood and may bias the at least one material container to an upright tilted position.
Other objects, features, and advantages of the present invention will become apparent from a consideration of the following detailed description.